ClearPoint Neuro (CLPT) risk factors, FY2025 10-K

Risks Related to Our Business and Industry

1. 01Our business, financial condition, and results of operations may be adversely affected by general economic and financial market conditions and current and future social and geopolitical instability83% rewritten
2. 02We may fail to realize the anticipated benefits of our acquisition of IRRAS, and the combined company may not perform as we or the market expect, which could adversely affect our business, results of operations, and the price of our common stockNew
3. 03be realized on the timeline anticipated, or at all. If we do not achieve these anticipated benefits, our financial condition, results of operations, and the market price of our common stock could be adversely affectedNew
4. 04the risk that we may be unable to expand the indications for use of IRRAflow beyond its current FDA-cleared labeling due to technical, clinical, regulatory, or market constraintsNew
5. 05If we cannot maintain our current relationships or programs, or enter into new relationships or programs, with drug delivery customers, our revenue prospects could be meaningfully reduced25% rewritten
6. 06The sizes of the markets for our products and services and any future products and services may be smaller than we estimate and may decline
7. 07Our ClearPoint system and our IRRAflow system may not achieve broad market adoption84% rewritten
8. 08physician perceptions that additional clinical data or real-world evidence is needed to support broader adoption of our technologiesNew
9. 09IRRAflow system to achieve meaningful market acceptance and penetration would harm our future prospects and have a material adverse effect on our business, financial condition, and results of operationsNew
10. 10allocating sales and clinical resources efficiently across two markets with different competitive landscapes and adoption curvesNew
11. 11secure our supply chain to ensure we can continue to deliver products in a timely fashion to all geographies90% rewritten
12. 12Limitations in the existing clinical evidence for the IRRAflow system may affect clinical and commercial adoptionNew
13. 13If coverage and reimbursement from third-party payors for procedures utilizing our products are inadequate, adoption of our products will be adversely affected and our revenues and prospects for profitability will suffer60% rewritten
14. 14and costly process that will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained or maintained if obtainedNew
15. 15We currently have significant customer concentration, so economic difficulties or changes in the purchasing policies or patterns of our key customers could have a significant impact on our business and operating results28% rewritten
16. 16We rely on single facilities for manufacturing and performance of services, which exposes us to significant risk of disruptionNew
17. 17Our reliance on single-source suppliers for components, finished products and services could harm our ability to meet demand for our products or services in a timely manner or within budget46% rewritten
18. 18Our use of hazardous materials in manufacturing and in the conduct of services may exposes us to significant health, safety, environmental, and regulatory risksNew
19. 19To the extent we seek a new indication for use of, or new claims for, our products, the FDA may not grant 510(k) clearance or PMA approval of such new use or claims, which may affect our ability to grow our business70% rewritten
20. 20If we fail to obtain the necessary clearances, certifications or approvals for our new products, our ability to grow our business globally could be harmed
21. 21There is no assurance that future clearance or approval of our new products will be granted, or that we will be able to continue selling our products in any geography. Such failures could hurt our ability to maintain and grow our businessNew
22. 22The markets for medical devices are highly competitive, and we may not be able to compete effectively against the larger, well-established companies in our markets or emerging and small innovative companies that may seek to obtain or increase their share of the market
23. 23significantly greater name recognition and more recognizable trademarks
24. 24We sell our products outside of the U.S., and we are subject to various economic, political, regulatory, and other risks relating to international operations, which could harm our revenue and profitability
25. 25changing regulatory environments such as the European Medical Device Regulation
26. 26Disruptions of critical information systems or material breaches in the security of our systems could harm our business, customer relations and financial condition
27. 27Our acquisition activities, including our recent acquisition of IRRAS, may expose us to heightened cybersecurity risks that could adversely affect our business, financial condition, and results of operationsNew
28. 28We may acquire other businesses, form joint ventures, or make investments in other companies or technologies that could harm our operating results, dilute our stockholders’ ownership, increase our debt, or cause us to incur significant expense22% rewritten
29. 29To finance any investments, acquisitions or joint ventures, it may be necessary for us to raise additional funds through public or private financings. Additional funds may not be available on terms that are favorable to us, or at allNew
30. 30We need to hire and retain additional qualified personnel to grow and manage our business. If we are unable to attract and retain qualified personnel, including our senior management team, our sales, clinical support and marketing team and our engineering team, our business and growth could be seriously harmed

Risks Related to Our Financial Position

1. 31We have incurred losses since our inception, and we may continue to incur losses. If we fail to generate significant revenue from sales of our products and services, we may never achieve or sustain profitability27% rewritten
2. 32Under the 2025 NPA, the aggregate amount of our indebtedness, as of December 31, 2025 was $50.9 millionNew
3. 33Further, in the event of default by us under the 2025 NPA, the lenders would be entitled to exercise their remedies thereunder, including the right to accelerate the debt, upon which we may be required to repay all amounts then outstanding under the 2025 NPA which would harm our financial conditionNew
4. 34Raising additional funds may cause dilution to existing stockholders, restrict our operations, or require us to relinquish proprietary rights45% rewritten
5. 35Our cash, cash equivalents and short-term marketable securities are subject to economic risk
6. 36We currently, and may in the future, have assets held at financial institutions that may exceed the insurance coverage offered by the Federal Deposit Insurance Corporation (“FDIC”), and the loss of such assets could have a negative effect on our operations and liquidity

Risks Related to Our Intellectual Property

1. 37If we, or the third parties from whom we license intellectual property, are unable to secure and maintain patent or other intellectual property protection for the intellectual property covering our marketed products or our product candidates, our ability to compete will be harmed
2. 38Others may assert that our products infringe their intellectual property rights, which may cause us to engage in costly disputes and, if we are not successful in defending ourselves, could also cause us to pay substantial damages and prohibit us from selling our marketed products
3. 39If the combination of patents, trade secrets and contractual provisions that we rely on to protect our intellectual property is inadequate, our ability to successfully commercialize our marketed products and product candidates will be harmed, and we may not be able to operate our business profitably
4. 40We rely on patent rights and licenses from third parties which are subject to termination or expiration
5. 41Third parties may attempt to commercialize competitive products in foreign countries where we do not have any patents or patent applications and/or where legal recourse may be limited. This may have a significant commercial impact on our foreign business operations
6. 42If we lose access to third-party software that is integrated into our products, our costs could increase and new installations of our products could be delayed, potentially hurting our competitive position
7. 43Our rights to develop and commercialize our products are subject, in part, to the terms and conditions of licenses granted to us by others

Risks Related to Legal and Regulatory Compliance

1. 44We operate in a highly-regulated industry and any failure to comply with the extensive government regulations may subject us to fines, injunctions and other penalties that could harm our business
2. 45refusing to grant export approval for our products
3. 46Federal legislation and other payment and policy changes may have a material adverse effect on our business45% rewritten
4. 47The success of our biologics and drug delivery business is dependent on timely regulatory approval and commercialization of cell and gene therapiesNew
5. 48A government shutdown or prolonged lapse in federal appropriations could materially delay or disrupt FDA review and approval processes critical to our business, which could have a material adverse effect on our financial condition and results of operationsNew
6. 49If our products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be subject to Medical Device Reporting regulations, which can result in voluntary corrective actions or agency enforcement actions
7. 50We have obtained 510(k) clearance of the products that we commercialize for defined indications. Promotion or marketing of our products for any indications for use other than that cleared by the FDA would be considered off-label use
8. 51If we or our third-party suppliers fail to comply with the FDA’s QMSR or any applicable state equivalent, our manufacturing operations could be interrupted, and our potential product sales and operating results could suffer
9. 52We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws and regulations and could face substantial penalties if we are unable to fully comply with such laws
10. 53assisting us with the technical evaluation of our methods, processes and devices related to their respective fields
11. 54We are subject to various laws and regulations protecting the confidentiality and security of certain patient health information, and our failure to comply with such laws and regulations could result in penalties and reputational damage25% rewritten

Risks Related to Our Common Stock

1. 55The market price of our common stock may be volatile, and a stockholder may not be able to resell their shares at or above the price at which the shares were purchased
2. 56Changes in the market valuations of similar companies;27% rewritten
3. 57Sales of our common stock by us or our stockholders in the future;New
4. 58Our ability to use net operating losses to offset future taxable income may be subject to certain limitations
5. 59We have not paid dividends in the past and do not expect to pay dividends in the future
6. 60Anti-takeover provisions in our certificate of incorporation, bylaws and Delaware law could prevent or delay a change in control
7. 61provide that stockholders will be permitted to amend our bylaws only upon receiving at least 66 2/3% of the votes entitled to be cast by holders of all outstanding shares then entitled to vote generally in the election of directors, voting together as a single class63% rewritten
8. 62Our Fourth Amended and Restated Bylaws further provide that the federal district courts of the U.S. will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act of 1933
9. 63We may fail to meet our publicly announced guidance or other expectations about our business and future operating results, which could cause a decline in our stock price
10. 64Securities analysts may not continue, or additional securities analysts may not initiate, coverage for our common stock or may issue negative reports. This may have a negative impact on the market price of our common stock
11. 65Damage to our reputation could harm our businesses, including our competitive position and business prospects
12. 66We have been, and could in the future become, subject to product liability or professional liability claims that could be expensive, divert management’s attention and harm our business
13. 67We may also be subject to professional liability for errors in the clinical support that we provide to clinicians in connection with our products or for a misunderstanding of, or inappropriate reliance upon, the information we provide
14. 68Our operations are vulnerable to interruption or loss due to natural disasters, power loss and other events beyond our control, which would adversely affect our business
15. 69The requirements of being a public company may strain our resources and distract management